SLE, Systemic Lupus Erythematosus
Conditions
Keywords
Systemic Lupus Erythematosus, Mycophenolate Mofetil (MMF)
Brief summary
This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF) on risk of clinically significant disease reactivation in quiescent SLE patients who have been on long-term MMF therapy.
Detailed description
Participants who have had inactive disease for at least 24 weeks will be enrolled. Half the subjects will continue on MMF and half the subjects will be tapered off their MMF within 12 weeks. All subjects will continue hydroxychloroquine and small doses of prednisone as needed. Subject visits to assess endpoints will occur every 4 weeks from Day 0 through Week 24 and then at Weeks 32, 40, 48, and 60.
Interventions
DRUGMycophenolate Mofetil
Subjects will enter the trial on 1000-3000 mg/day of MMF and will be randomized to remain on MMF treatment or to be tapered off MMF within 12 weeks.
DRUGHydroxychloroquine or Chloroquine
Subjects will be on concurrent anti-malarial agents (hydroxychloroquine or chloroquine). Hydroxychloroquine is approved by the FDA for the treatment of SLE. Hydroxychloroquine has been shown to help prevent flare in SLE, and to improve skin and musculoskeletal activity in particular.Even lupus nephritis outcomes appear improved on a background of hydroxychloroquine therapy
DRUGPrednisone
Once the subject is randomized into the trial, the prednisone (or other corticosteroid) dose must be stable through Week 36 (24 weeks following protocol taper of MMF), in the absence of flares as described in Section 3.2 of the study protocol, Description of Primary Endpoint. Further taper of prednisone after that point is by the investigator's discretion based on the subject's clinical status.
Sponsors
Autoimmunity Centers of Excellence
Rho Federal Systems Division, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Able and willing to give written informed consent and comply with requirements of the study; 2. Age 18 - 70 years, inclusive, at randomization; 3. Diagnosis of SLE, per the American College of Rheumatology (ACR) criteria; 4. m-SLEDAI score \< 4 at screening visit (SLEDAI score without serologies); 5. Physician Global Assessment (0-3) score of 1 or less at screening visit; 6. On a stable dose of MMF (1000-3000 mg/day) for at least 12 weeks prior to randomization; 7. Total duration of stable or decreasing MMF therapy must be at least: * two years for subjects initiating MMF for renal indications (with or without concurrent extra-renal manifestations), or * one year for subjects initiating MMF for extra-renal indications. 8. If the subject is on prednisone or other corticosteroid, the following criteria must be met: * the dose may not exceed 10 mg/day (or its equivalent) for the 12 weeks prior to randomization; however, temporary (up to 4 total days) increases, not to exceed 20mg/day, are permitted; * the dose must be held stable for the four weeks prior to randomization (no temporary increases within 4 weeks of randomization are permitted). 9. If the subject has a history of B cell depleting therapy within the past 3 years, presence of CD19 positive cells must be documented within 12 weeks prior to screening; 10. On maintenance HCQ or chloroquine at a stable dose for at least 12 weeks prior to randomization.
Exclusion criteria
1. A history of life-threatening neuropsychiatric SLE within 1 calendar year prior to randomization; 2. Any of the following laboratory abnormalities at the screening visit: * Proteinuria as defined by a spot protein/creatinine ratio \> 1.0 mg/mg; * Serum creatinine \> 2.0 mg/dL; * Transaminases \> 2.5x the upper limit of normal (ULN); * Hemoglobin \< 9 g/dL, unless the subject has documented hemoglobinopathy; * White blood count (WBC) \< 2000/mm\^3 (equivalent to \< 2 x10\^9/L); * Neutrophils \< 1000/mm\^3 (equivalent to \< 1 x10\^9/L); or * Platelet count \< 75,000/mm\^3 (equivalent to \< 75 x 10\^9/L). 3. Prednisone \> 25 mg/day (or its equivalent) within 24 weeks prior to randomization for lupus activity; 4. Concomitant immunosuppressants including but not limited to azathioprine, methotrexate, 6-mercaptopurine, leflunomide, calcineurin inhibitors, anti-tumor necrosis factor agents within 12 weeks prior to randomization; 5. Plasmapheresis or IV immunoglobulin within 12 weeks prior to randomization; 6. Cyclophosphamide therapy within 24 weeks prior to randomization; 7. Concomitant therapy with belimumab within 24 weeks prior to randomization; 8. B cell depleting therapy within two calendar years of randomization; 9. Experimental therapy within the 24 weeks, or five half-lives of the agent, whichever is longer, prior to randomization; 10. Solid organ or stem cell transplantation; 11. Identified definitive diagnosis of another autoimmune disease that may require immunosuppression for treatment, including but not limited to: rheumatoid arthritis, scleroderma, primary Sjogren's syndrome, primary vasculitis, psoriasis, multiple sclerosis, ankylosing spondylitis, and inflammatory bowel disease. 12. Chronic infections including, but not limited to, human immunodeficiency virus (HIV), active tuberculosis (TB), currently receiving therapy)), hepatitis B or hepatitis C, or latent systemic fungal infection; 13. At or within 12 weeks of screening: * a history of or current positive purified protein derivative (PPD) (\> 5 mm induration regardless of prior Bacillus Calmette-Guérin (BCG) vaccine administration) or positive QuantiFERON unless documentation exists of completion of at least one month of prophylaxis for latent TB or completed treatment for active TB; or * an indeterminate QuantiFERON® unless followed by a subsequent negative PPD or negative QuantiFERON. 14. History of malignancy within the last five years, except for resected basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ cervical cancer Grade I; 15. Pregnant or lactating, or intention to pursue pregnancy within three months after the completion of the study; 16. Unable or unwilling to use reliable methods of contraception, as outlined in the Mycophenolate REMS (e.g., Risk Evaluation and Mitigation Strategy), from four weeks prior to randomization to 6 weeks after completion of the study. This criterion applies to females of reproductive potential. (Reference: Mycophenolate REMS, Program Resources and Educational Materials, Information for Patients, What are my birth control options? Access the link at: (https://www.mycophenolaterems.com/PatientOverview.aspx). 17. Drug or alcohol abuse within one calendar year of randomization; 18. Other medical or psychiatric conditions that the investigator feels would place the subject at special risk by participation in this protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Clinically Significant Disease Reactivation by Week 60 | Baseline (Treatment Randomization) to Week 60 | Disease reactivation requires:1) SELENA-SLEDAI mild/moderate or severe flare,and 2) Increased immunosuppressive therapy on a sustained basis,defined by one of the following criteria:a) Sustained activity:Significant prolonged SLE flare requiring steroid increase/burst to ≥15 mg/day prednisone (or equivalent) for \>4 weeks.b) Frequent relapsing/remitting:Participant flares requiring an increase/burst of steroids and is successfully tapered to \<15 mg/day within 4 weeks, but this occurs on \>2 occasions, or IA, IM or IV steroids on more than1 occasion.c)Clinical activity of sufficient severity to warrant resumption of/increased dose of MMF or addition of other major immunosuppressive including AZA or MTX.Regardless of steroid use, if the investigator observes disease activity of sufficient severity to warrant resumption, addition or increase in dosage of major immunosuppressant in the setting of a SELENA-SLEDAI flare, participant has met the primary endpoint.Risk difference also included |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 | Baseline (Treatment Randomization) to Week 60 | The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. |
| Cumulative Systemic Steroid Dose by Week 60 | Baseline (Treatment Randomization) to Week 60 | Steroids include medications that code to a medication class which includes the terms glucocorticoid or corticosteroid. Systemic steroids will include any of these steroids that are taken by mouth (PO), intravenous (IV), or intramuscular (IM). Total cumulative systemic steroid dose, in milligrams, was summarized over the 60 week study period, or until early study termination, for each participant. |
| Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup | Baseline (Treatment Randomization) to Week 60 | The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. |
| Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup | Baseline (Treatment Randomization) to Week 60 | The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. |
| Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF<2000 mg/Day Subgroup | Baseline (Treatment Randomization) to Week 60 | The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. MMF: mycophenolate mofetil |
| Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup | Baseline (Treatment Randomization) to Week 60 | The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. MMF: mycophenolate mofetil |
| Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 | Baseline (Treatment Randomization) to Week 60 | The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. |
| Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup | Baseline (Treatment Randomization) to Week 60 | The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. |
| Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup | Baseline (Treatment Randomization) to Week 60 | The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. |
| Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF <2000 mg/Day Subgroup | Baseline (Treatment Randomization) to Week 60 | The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. MMF: mycophenolate mofetil |
| Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup | Baseline (Treatment Randomization) to Week 60 | The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. MMF: mycophenolate mofetil |
| Time to First Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare | Baseline (Treatment Randomization) to Week 60 | The time to first mild/moderate or severe SELENA-SLEDAI flare was defined as the time from Baseline/Day 0 to the date of the first mild/moderate or severe SELENA-SLEDAI flare. Time to SELENA-SLEDAI flare was defined in study weeks as: date of SELENA-SLEDAI flare minus (-) baseline date. The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. |
| Time to First Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare | Baseline (Treatment Randomization) to Week 60 | The time to first severe SELENA-SLEDAI flare was defined as the time from Baseline/Day 0 to the date of the first severe SELENA-SLEDAI flare. Time to severe SELENA-SLEDAI flare was defined in study weeks as: date of SELENA-SLEDAI flare minus (-) baseline date. The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. |
| Number of Participants Experiencing Any British Isles Lupus Assessment Group (BILAG) A Flare by Week 60 | Baseline (Treatment Randomization) to Week 60 | The BILAG assesses participants on a variety of disease activity criteria in nine body system categories (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematological). Each category is scored as an A, B, C, or D/E, where A indicates most severe disease activity and D/E indicates inactive/no disease activity. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. |
| Number of Participants in the Lupus Nephritis Subgroup Experiencing a British Isles Lupus Assessment Group (BILAG) A Renal Flare by Week 60 | Baseline (Treatment Randomization) to Week 60 | The BILAG assesses participants on a variety of disease activity criteria in nine body system categories (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematological). Each category is scored as an A, B, C, or D/E, where A indicates most severe disease activity and D/E indicates inactive/no disease activity. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. |
| Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Disease Damage Index for Systemic Lupus Erythematosus (SLICC/DI): Total Score | Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60 | The SLICC/DI measures accumulated damage that has occurred since the onset of systemic lupus erythematosus (SLE), regardless of cause, in 12 organ systems. SLE damage is defined as an irreversible change in an organ or system that has been present for at least 6 months. The SLICC/DI includes 39 areas of damage in 12 domains, where each item is rated as present or absent; if evidence of damage is present for a particular item, it is given a score of 1. Some items are scored with 2 or 3 points in the case of recurring events or end stage renal disease. The SLICC/DI total score will be computed as the sum of all scores for items indicated as present; scores can range from 0 to 45. Higher scores indicate more damage. |
| The Addition of Aggressive Adjunctive Therapy to Mycophenolate Mofetil (MMF) or Change in MMF Therapy to Cytotoxic Drug Due to Flare by Week 60 | Baseline (Treatment Randomization) to Week 60 | The addition of aggressive adjunctive therapy could include intravenous (IV) immunoglobulin or rituximab at any point during the participant's study participation. A change in therapy to cytotoxic drug due to flare could include drugs such as cyclophosphamide, etc. A blinded list of study medications was reviewed to identify the addition of aggressive adjunctive therapy or cytotoxic drugs. |
| Time to Clinically Significant Disease Reactivation | Baseline (Treatment Randomization) to Week 60 | The time to clinically significant disease reactivation was defined as the time from Baseline/Day 0 to the date of the first Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) assessment that met (or went on to meet) the criteria for clinically significant disease reactivation. Time to clinically significant disease reactivation was defined in study weeks as: date of SELENA-SLEDAI assessment that met reactivation criteria minus (-) baseline date. |
| Change From Baseline in the Short Form Health Survey (SF-36) Physical Functioning (PF) Score | Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60 | The SF-36 is a 36-item, patient-reported survey of patient health. Higher scores indicate better outcomes while lower scores indicate more disability. The PF score is used to assess changes in physical functioning. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. |
| Change From Baseline in the Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score | Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60 | The SF-36 is a 36-item, patient-reported survey of patient health. Higher scores indicate better outcomes while lower scores indicate more disability. The Physical Component Score is comprised of the Physical Functioning Scale, the Role-Physical Scale, the Bodily Pain Scale, and the General Health Scale. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability. |
| Change From Baseline in the Lupus Quality of Life (QoL)Score | Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60 | The Lupus QoL assessment is a 34 item questionnaire across 8 domains that is designed to find out how systemic lupus erythematosus (SLE) affects a participant's life over the preceding 4 weeks. Scores range from 0 (worst QoL) to 100 (best QoL). Domains include physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue. |
| Time From Clinically Significant Disease Reactivation to Improvement in British Isles Lupus Assessment Group (BILAG) From Maximum Level During Flare | Baseline (Treatment Randomization) to Week 60 | For each participant who experienced disease reactivation, time from clinically significant disease reactivation to improvement in BILAG from maximum level (at least an A or B) during the flare was calculated in study days as: date of clinically significant disease reactivation minus (-) date of BILAG improvement. If multiple body systems had a BILAG flare at the visit, then the body system with the most severe score was tracked for improvement; if multiple body systems had the same score (at least an A or B), then just one needed to show improvement. |
| Time From Clinically Significant Disease Reactivation to Recovery to Baseline British Isles Lupus Assessment Group (BILAG) Score or BILAG C | Baseline (Treatment Randomization) to Week 60 | For each participant who experienced disease reactivation, time from clinically significant disease reactivation to recovery to baseline BILAG scores or BILAG C, whichever is worse, was calculated in study days as: date of clinically significant disease reactivation minus (-) date of BILAG recovery. |
| Cumulative Excess Systemic Steroid Dose From Time of Clinically Significant Disease Reactivation to Return to Pre-Flare Dose or End of Trial Participation | Baseline (Treatment Randomization) to Week 60 | For each participant who experienced disease reactivation, excess systemic steroid dose was summed from the time of clinically significant disease reactivation until the dose returns to pre-flare levels or the end of study participation, whichever occurred first. Excess systemic steroid dose was defined as the total dose given for the flare minus (-) a participant's pre-flare steroid dose. Participants who do not have an increase in their steroid use due to the flare had their excess dose set to zero. Steroids include medications that code to a medication class which includes the terms glucocorticoid or corticosteroid. Systemic steroids will include any of these steroids that are taken by mouth (PO), intravenous (IV), or intramuscular (IM). |
| Time From Clinically Significant Disease Reactivation to Return to Pre-Flare Steroid Dose | Baseline (Treatment Randomization) to Week 60 | For each participant who experienced disease reactivation, time from clinically significant disease reactivation to recovery to pre-flare steroid dose was calculated in study days as: date of clinically significant disease reactivation minus (-) date of return to pre-flare steroid dose. |
| Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Systemic Lupus Erythematosus (SLE) | Baseline (Treatment Randomization) to Week 60 | The number of Grade 3, 4, or 5 AEs classified as possibly, probably, or definitely related to SLE. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. |
| Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Mycophenolate Mofetil (MMF) | Baseline (Treatment Randomization) to Week 60 | The number of Grade 3, 4, or 5 AEs classified as possibly, probably, or definitely related to MMF. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. |
| Number of Grade 3, 4, or 5 Adverse Events (AEs) | Baseline (Treatment Randomization) to Week 60 | The number of Grade 3, 4, or 5 AEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. |
| Number of Serious Adverse Events (SAEs). | Baseline (Treatment Randomization) to Week 60 | The number of SAEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. |
| Number of Infection-Related Adverse Events (AEs) | Baseline (Treatment Randomization) to Week 60 | The number of AEs classified as infections. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. |
| Number of Malignancies Reported as Adverse Events (AEs). | Baseline (Treatment Randomization) to Week 60 | The number of malignancies reported as AEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. |
| Number of Grade 3, 4, or 5 Hematological Adverse Events (AEs). | Baseline (Treatment Randomization) to Week 60 | The number of Grade 3, 4, or 5 hematological AEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. |
| Mortality Related to Systemic Lupus Erythematosus (SLE) | Baseline (Treatment Randomization) to Week 60 | Mortality related to SLE is defined as any death possibly, probably, or definitely related to SLE. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. |
| All-Cause Mortality | Baseline (Treatment Randomization) to Week 60 | All-cause mortality is defined as death from any cause occurring after randomization. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0. |
| Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT-F) Fatigue Scale (FS): Total Score | Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60 | FACIT-Fatigue scale (FS) is a 13-item questionnaire completed by the patient (participant), that provides a measure of fatigue/quality of life, with a 7-day recall period. The participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. A decrease in the FACIT-FS score reflects worse fatigue/quality of life. |
Countries
United States
Participant flow
Recruitment details
Nineteen study sites in the US were activated. A total of 123 participants were screened and 102 were randomized from November 2013 to May 2018.
Participants by arm
| Arm | Count |
|---|---|
| Maintenance Participants received Mycophenolate Mofetil (MMF) treatment (1000-3000 mg/day) for the rest of their study participation (up to Week 60). | 50 |
| Withdrawal Participants tapered off Mycophenolate Mofetil (MMF) per the protocol-specified schedule over 12 weeks and remained off MMF for the rest of their study participation (up to Week 60 or until the primary endpoint of disease reactivation was met, whichever came first). | 52 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Met Primary Endpoint | 1 | 0 |
| Overall Study | Personal and Family Issues | 1 | 0 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Maintenance | Withdrawal | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 50 Participants | 98 Participants |
| Age, Continuous | 42.4 years STANDARD_DEVIATION 12.9 | 41.6 years STANDARD_DEVIATION 12.5 | 42.0 years STANDARD_DEVIATION 12.6 |
| Baseline MMF Dose < 2000 mg/day | 26 Participants | 30 Participants | 56 Participants |
| Baseline MMF Dose ≥ 2000 mg/day | 24 Participants | 22 Participants | 46 Participants |
| Disease Manifestation: Renal vs. Non-Renal Disease Non-Renal Disease | 10 Participants | 14 Participants | 24 Participants |
| Disease Manifestation: Renal vs. Non-Renal Disease Renal Disease | 40 Participants | 38 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 12 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 40 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 8 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 22 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 25 Participants | 17 Participants | 42 Participants |
| Region of Enrollment United States | 50 Participants | 52 Participants | 102 Participants |
| Sex: Female, Male Female | 39 Participants | 47 Participants | 86 Participants |
| Sex: Female, Male Male | 11 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 52 |
| other Total, other adverse events | 38 / 50 | 41 / 52 |
| serious Total, serious adverse events | 7 / 50 | 5 / 52 |
Outcome results
Primary
Number of Participants Experiencing Clinically Significant Disease Reactivation by Week 60
Disease reactivation requires:1) SELENA-SLEDAI mild/moderate or severe flare,and 2) Increased immunosuppressive therapy on a sustained basis,defined by one of the following criteria:a) Sustained activity:Significant prolonged SLE flare requiring steroid increase/burst to ≥15 mg/day prednisone (or equivalent) for \>4 weeks.b) Frequent relapsing/remitting:Participant flares requiring an increase/burst of steroids and is successfully tapered to \<15 mg/day within 4 weeks, but this occurs on \>2 occasions, or IA, IM or IV steroids on more than1 occasion.c)Clinical activity of sufficient severity to warrant resumption of/increased dose of MMF or addition of other major immunosuppressive including AZA or MTX.Regardless of steroid use, if the investigator observes disease activity of sufficient severity to warrant resumption, addition or increase in dosage of major immunosuppressant in the setting of a SELENA-SLEDAI flare, participant has met the primary endpoint.Risk difference also included
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | Number of Participants Experiencing Clinically Significant Disease Reactivation by Week 60 | 5 Participants |
| MMF Withdrawal | Number of Participants Experiencing Clinically Significant Disease Reactivation by Week 60 | 9 Participants |
95% CI: [-0.068, 0.214]
Secondary
All-Cause Mortality
All-cause mortality is defined as death from any cause occurring after randomization. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The safety population (SP) includes all participants for whom study intervention was initiated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | All-Cause Mortality | 0 Participants |
| MMF Withdrawal | All-Cause Mortality | 0 Participants |
Secondary
Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT-F) Fatigue Scale (FS): Total Score
FACIT-Fatigue scale (FS) is a 13-item questionnaire completed by the patient (participant), that provides a measure of fatigue/quality of life, with a 7-day recall period. The participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response. The sum of all responses resulted in the FACIT-FS score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status. A decrease in the FACIT-FS score reflects worse fatigue/quality of life.
Time frame: Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMF Maintenance | Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT-F) Fatigue Scale (FS): Total Score | Week 24 | -2.41 units on a scale | Standard Deviation 8.13 |
| MMF Maintenance | Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT-F) Fatigue Scale (FS): Total Score | Week 48 | -3.39 units on a scale | Standard Deviation 7.53 |
| MMF Maintenance | Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT-F) Fatigue Scale (FS): Total Score | Week 60 | -3.13 units on a scale | Standard Deviation 8.82 |
| MMF Withdrawal | Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT-F) Fatigue Scale (FS): Total Score | Week 24 | -0.81 units on a scale | Standard Deviation 10.62 |
| MMF Withdrawal | Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT-F) Fatigue Scale (FS): Total Score | Week 48 | -0.85 units on a scale | Standard Deviation 9.75 |
| MMF Withdrawal | Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT-F) Fatigue Scale (FS): Total Score | Week 60 | 0.42 units on a scale | Standard Deviation 9.05 |
Comparison: Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 24.95% CI: [-2.24, 5.45]
Comparison: Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 48.95% CI: [-1.13, 6.21]
Comparison: Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the FACIT fatigue score between the treatment groups at Week 60.95% CI: [-0.17, 7.28]
Secondary
Change From Baseline in the Lupus Quality of Life (QoL)Score
The Lupus QoL assessment is a 34 item questionnaire across 8 domains that is designed to find out how systemic lupus erythematosus (SLE) affects a participant's life over the preceding 4 weeks. Scores range from 0 (worst QoL) to 100 (best QoL). Domains include physical health, pain, planning, intimate relationships, burden to others, emotional health, body image, and fatigue.
Time frame: Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Planning at Week 24 | 0.35 Scores on a Scale | Standard Deviation 16.75 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Physical Health at Week 48 | -2.83 Scores on a Scale | Standard Deviation 11.57 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Physical Health at Week 60 | 0.00 Scores on a Scale | Standard Deviation 9.02 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Pain at Week 24 | -0.17 Scores on a Scale | Standard Deviation 10.67 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Pain at Week 48 | -3.10 Scores on a Scale | Standard Deviation 12.73 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Pain at Week 60 | -0.19 Scores on a Scale | Standard Deviation 12.39 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Physical Health at Week 24 | -1.11 Scores on a Scale | Standard Deviation 9.2 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Planning at Week 48 | -5.43 Scores on a Scale | Standard Deviation 16.66 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Intimate Relationships at Week 24 | -1.47 Scores on a Scale | Standard Deviation 23.39 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Intimate Relationships at Week 48 | -0.81 Scores on a Scale | Standard Deviation 10.67 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Intimate Relationships at Week 60 | -2.08 Scores on a Scale | Standard Deviation 10.93 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Burden to Others at Week 24 | 1.56 Scores on a Scale | Standard Deviation 21.99 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Burden to Others at Week 48 | -0.58 Scores on a Scale | Standard Deviation 16.2 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Burden to Others at Week 60 | -1.33 Scores on a Scale | Standard Deviation 17.14 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Emotional Health at Week 24 | -0.87 Scores on a Scale | Standard Deviation 18.57 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Emotional Health at Week 48 | -2.03 Scores on a Scale | Standard Deviation 15.71 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Emotional Health at Week 60 | -1.52 Scores on a Scale | Standard Deviation 17.1 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Body Image at Week 24 | 2.94 Scores on a Scale | Standard Deviation 16.12 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Body Image at Week 48 | -0.17 Scores on a Scale | Standard Deviation 14.84 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Body Image at Week 60 | 3.22 Scores on a Scale | Standard Deviation 15.29 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Fatigue at Week 24 | 3.78 Scores on a Scale | Standard Deviation 16.04 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Fatigue at Week 48 | -2.18 Scores on a Scale | Standard Deviation 18.04 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Fatigue at Week 60 | -0.57 Scores on a Scale | Standard Deviation 15.36 |
| MMF Maintenance | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Planning at Week 60 | -3.03 Scores on a Scale | Standard Deviation 16.48 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Fatigue at Week 60 | -1.95 Scores on a Scale | Standard Deviation 17.69 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Physical Health at Week 24 | 1.04 Scores on a Scale | Standard Deviation 17.66 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Burden to Others at Week 48 | -4.43 Scores on a Scale | Standard Deviation 16.56 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Physical Health at Week 48 | 0.46 Scores on a Scale | Standard Deviation 14.06 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Body Image at Week 60 | -4.45 Scores on a Scale | Standard Deviation 20.15 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Physical Health at Week 60 | 1.56 Scores on a Scale | Standard Deviation 13.18 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Emotional Health at Week 48 | -1.22 Scores on a Scale | Standard Deviation 15.13 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Pain at Week 24 | 1.77 Scores on a Scale | Standard Deviation 18.87 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Emotional Health at Week 24 | 0.09 Scores on a Scale | Standard Deviation 13.02 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Pain at Week 48 | 1.60 Scores on a Scale | Standard Deviation 16.72 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Fatigue at Week 24 | -1.17 Scores on a Scale | Standard Deviation 20.74 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Pain at Week 60 | 1.42 Scores on a Scale | Standard Deviation 14.36 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Planning at Week 60 | 0.18 Scores on a Scale | Standard Deviation 17.76 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Planning at Week 24 | 3.90 Scores on a Scale | Standard Deviation 17.28 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Emotional Health at Week 60 | -0.87 Scores on a Scale | Standard Deviation 13.06 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Planning at Week 48 | -0.18 Scores on a Scale | Standard Deviation 18.59 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Fatigue at Week 48 | -1.56 Scores on a Scale | Standard Deviation 17.37 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Intimate Relationships at Week 24 | 4.29 Scores on a Scale | Standard Deviation 18.68 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Body Image at Week 24 | -1.09 Scores on a Scale | Standard Deviation 15.61 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Intimate Relationships at Week 48 | -1.10 Scores on a Scale | Standard Deviation 14.88 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Burden to Others at Week 60 | -3.55 Scores on a Scale | Standard Deviation 18.78 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Intimate Relationships at Week 60 | 2.86 Scores on a Scale | Standard Deviation 13.92 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Body Image at Week 48 | -0.56 Scores on a Scale | Standard Deviation 17.76 |
| MMF Withdrawal | Change From Baseline in the Lupus Quality of Life (QoL)Score | Change in Burden to Others at Week 24 | 0.18 Scores on a Scale | Standard Deviation 20.3 |
Secondary
Change From Baseline in the Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
The SF-36 is a 36-item, patient-reported survey of patient health. Higher scores indicate better outcomes while lower scores indicate more disability. The Physical Component Score is comprised of the Physical Functioning Scale, the Role-Physical Scale, the Bodily Pain Scale, and the General Health Scale. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability.
Time frame: Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMF Maintenance | Change From Baseline in the Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score | Week 24 | -0.75 Scores on a Scale | Standard Deviation 4.82 |
| MMF Maintenance | Change From Baseline in the Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score | Week 48 | -1.92 Scores on a Scale | Standard Deviation 6.69 |
| MMF Maintenance | Change From Baseline in the Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score | Week 60 | -1.51 Scores on a Scale | Standard Deviation 6.66 |
| MMF Withdrawal | Change From Baseline in the Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score | Week 24 | 0.90 Scores on a Scale | Standard Deviation 7.96 |
| MMF Withdrawal | Change From Baseline in the Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score | Week 60 | 1.51 Scores on a Scale | Standard Deviation 6.76 |
| MMF Withdrawal | Change From Baseline in the Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score | Week 48 | 0.25 Scores on a Scale | Standard Deviation 6.83 |
Comparison: Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 24.95% CI: [-1.03, 4.32]
Comparison: Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 48.95% CI: [-0.69, 5.02]
Comparison: Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PCS score between the treatment groups at Week 60.95% CI: [0.22, 5.82]
Secondary
Change From Baseline in the Short Form Health Survey (SF-36) Physical Functioning (PF) Score
The SF-36 is a 36-item, patient-reported survey of patient health. Higher scores indicate better outcomes while lower scores indicate more disability. The PF score is used to assess changes in physical functioning. It is scaled from 0 to 100 with a score of 0 equivalent to maximum disability and a score of 100 equivalent to no disability.
Time frame: Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMF Maintenance | Change From Baseline in the Short Form Health Survey (SF-36) Physical Functioning (PF) Score | Week 24 | -0.33 Scores on a Scale | Standard Deviation 4.05 |
| MMF Maintenance | Change From Baseline in the Short Form Health Survey (SF-36) Physical Functioning (PF) Score | Week 48 | -0.49 Scores on a Scale | Standard Deviation 6.21 |
| MMF Maintenance | Change From Baseline in the Short Form Health Survey (SF-36) Physical Functioning (PF) Score | Week 60 | -0.19 Scores on a Scale | Standard Deviation 5.63 |
| MMF Withdrawal | Change From Baseline in the Short Form Health Survey (SF-36) Physical Functioning (PF) Score | Week 24 | 0.22 Scores on a Scale | Standard Deviation 7.2 |
| MMF Withdrawal | Change From Baseline in the Short Form Health Survey (SF-36) Physical Functioning (PF) Score | Week 48 | 0.95 Scores on a Scale | Standard Deviation 6.13 |
| MMF Withdrawal | Change From Baseline in the Short Form Health Survey (SF-36) Physical Functioning (PF) Score | Week 60 | 1.79 Scores on a Scale | Standard Deviation 7.13 |
Comparison: Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 24.95% CI: [-1.82, 2.92]
Comparison: Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 48.95% CI: [-1.14, 4.03]
Comparison: Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the PF score between the treatment groups at Week 60.95% CI: [-0.71, 4.67]
Secondary
Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Disease Damage Index for Systemic Lupus Erythematosus (SLICC/DI): Total Score
The SLICC/DI measures accumulated damage that has occurred since the onset of systemic lupus erythematosus (SLE), regardless of cause, in 12 organ systems. SLE damage is defined as an irreversible change in an organ or system that has been present for at least 6 months. The SLICC/DI includes 39 areas of damage in 12 domains, where each item is rated as present or absent; if evidence of damage is present for a particular item, it is given a score of 1. Some items are scored with 2 or 3 points in the case of recurring events or end stage renal disease. The SLICC/DI total score will be computed as the sum of all scores for items indicated as present; scores can range from 0 to 45. Higher scores indicate more damage.
Time frame: Baseline (Treatment Randomization) to Week 24, Week 48, and Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMF Maintenance | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Disease Damage Index for Systemic Lupus Erythematosus (SLICC/DI): Total Score | Week 24 | 0.0 Scores on a Scale | Standard Deviation 0.15 |
| MMF Maintenance | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Disease Damage Index for Systemic Lupus Erythematosus (SLICC/DI): Total Score | Week 48 | 0.0 Scores on a Scale | Standard Deviation 0.22 |
| MMF Maintenance | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Disease Damage Index for Systemic Lupus Erythematosus (SLICC/DI): Total Score | Week 60 | 0.0 Scores on a Scale | Standard Deviation 0.37 |
| MMF Withdrawal | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Disease Damage Index for Systemic Lupus Erythematosus (SLICC/DI): Total Score | Week 24 | 0.0 Scores on a Scale | Standard Deviation 0.15 |
| MMF Withdrawal | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Disease Damage Index for Systemic Lupus Erythematosus (SLICC/DI): Total Score | Week 48 | 0.0 Scores on a Scale | Standard Deviation 0.15 |
| MMF Withdrawal | Change From Baseline in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Disease Damage Index for Systemic Lupus Erythematosus (SLICC/DI): Total Score | Week 60 | 0.0 Scores on a Scale | Standard Deviation 0.21 |
Comparison: Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 24.95% CI: [-0.1, 0.1]
Comparison: Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 48.95% CI: [-0.1, 0.1]
Comparison: Descriptive statistics (mean and 95% confidence interval) are reported for the difference in the change from baseline in the SLICC/DI score between the treatment groups at Week 60.95% CI: [-0.2, 0.1]
Secondary
Cumulative Excess Systemic Steroid Dose From Time of Clinically Significant Disease Reactivation to Return to Pre-Flare Dose or End of Trial Participation
For each participant who experienced disease reactivation, excess systemic steroid dose was summed from the time of clinically significant disease reactivation until the dose returns to pre-flare levels or the end of study participation, whichever occurred first. Excess systemic steroid dose was defined as the total dose given for the flare minus (-) a participant's pre-flare steroid dose. Participants who do not have an increase in their steroid use due to the flare had their excess dose set to zero. Steroids include medications that code to a medication class which includes the terms glucocorticoid or corticosteroid. Systemic steroids will include any of these steroids that are taken by mouth (PO), intravenous (IV), or intramuscular (IM).
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups they were randomized. Participants who met primary endpoint were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MMF Maintenance | Cumulative Excess Systemic Steroid Dose From Time of Clinically Significant Disease Reactivation to Return to Pre-Flare Dose or End of Trial Participation | 812.8 Steroid dose (mg) | Standard Deviation 561.6 |
| MMF Withdrawal | Cumulative Excess Systemic Steroid Dose From Time of Clinically Significant Disease Reactivation to Return to Pre-Flare Dose or End of Trial Participation | 1750.7 Steroid dose (mg) | Standard Deviation 3384.6 |
Secondary
Cumulative Systemic Steroid Dose by Week 60
Steroids include medications that code to a medication class which includes the terms glucocorticoid or corticosteroid. Systemic steroids will include any of these steroids that are taken by mouth (PO), intravenous (IV), or intramuscular (IM). Total cumulative systemic steroid dose, in milligrams, was summarized over the 60 week study period, or until early study termination, for each participant.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MMF Maintenance | Cumulative Systemic Steroid Dose by Week 60 | 851 steroid dose (mg) | Standard Deviation 1148 |
| MMF Withdrawal | Cumulative Systemic Steroid Dose by Week 60 | 912 steroid dose (mg) | Standard Deviation 1995 |
Secondary
Mortality Related to Systemic Lupus Erythematosus (SLE)
Mortality related to SLE is defined as any death possibly, probably, or definitely related to SLE. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The safety population (SP) includes all participants for whom study intervention was initiated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | Mortality Related to Systemic Lupus Erythematosus (SLE) | 0 Participants |
| MMF Withdrawal | Mortality Related to Systemic Lupus Erythematosus (SLE) | 0 Participants |
Secondary
Number of Grade 3, 4, or 5 Adverse Events (AEs)
The number of Grade 3, 4, or 5 AEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The safety population (SP) includes all participants for whom study intervention was initiated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MMF Maintenance | Number of Grade 3, 4, or 5 Adverse Events (AEs) | Grade 3 | 18 Adverse Events |
| MMF Maintenance | Number of Grade 3, 4, or 5 Adverse Events (AEs) | Grade 4 | 2 Adverse Events |
| MMF Maintenance | Number of Grade 3, 4, or 5 Adverse Events (AEs) | Grade 5 | 0 Adverse Events |
| MMF Withdrawal | Number of Grade 3, 4, or 5 Adverse Events (AEs) | Grade 4 | 0 Adverse Events |
| MMF Withdrawal | Number of Grade 3, 4, or 5 Adverse Events (AEs) | Grade 5 | 0 Adverse Events |
| MMF Withdrawal | Number of Grade 3, 4, or 5 Adverse Events (AEs) | Grade 3 | 15 Adverse Events |
Secondary
Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Mycophenolate Mofetil (MMF)
The number of Grade 3, 4, or 5 AEs classified as possibly, probably, or definitely related to MMF. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The safety population (SP) includes all participants for whom study intervention was initiated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MMF Maintenance | Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Mycophenolate Mofetil (MMF) | Grade 4 | 0 Adverse Events |
| MMF Maintenance | Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Mycophenolate Mofetil (MMF) | Grade 5 | 0 Adverse Events |
| MMF Maintenance | Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Mycophenolate Mofetil (MMF) | Grade 3 | 7 Adverse Events |
| MMF Withdrawal | Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Mycophenolate Mofetil (MMF) | Grade 3 | 1 Adverse Events |
| MMF Withdrawal | Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Mycophenolate Mofetil (MMF) | Grade 4 | 0 Adverse Events |
| MMF Withdrawal | Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Mycophenolate Mofetil (MMF) | Grade 5 | 0 Adverse Events |
Secondary
Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Systemic Lupus Erythematosus (SLE)
The number of Grade 3, 4, or 5 AEs classified as possibly, probably, or definitely related to SLE. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The safety population (SP) includes all participants for whom study intervention was initiated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MMF Maintenance | Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Systemic Lupus Erythematosus (SLE) | Grade 3 | 6 Adverse Events |
| MMF Maintenance | Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Systemic Lupus Erythematosus (SLE) | Grade 4 | 0 Adverse Events |
| MMF Maintenance | Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Systemic Lupus Erythematosus (SLE) | Grade 5 | 0 Adverse Events |
| MMF Withdrawal | Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Systemic Lupus Erythematosus (SLE) | Grade 3 | 5 Adverse Events |
| MMF Withdrawal | Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Systemic Lupus Erythematosus (SLE) | Grade 4 | 0 Adverse Events |
| MMF Withdrawal | Number of Grade 3, 4, or 5 Adverse Events (AEs) Related to Systemic Lupus Erythematosus (SLE) | Grade 5 | 0 Adverse Events |
Secondary
Number of Grade 3, 4, or 5 Hematological Adverse Events (AEs).
The number of Grade 3, 4, or 5 hematological AEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The safety population (SP) includes all participants for whom study intervention was initiated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MMF Maintenance | Number of Grade 3, 4, or 5 Hematological Adverse Events (AEs). | Grade 3 | 3 Adverse Events |
| MMF Maintenance | Number of Grade 3, 4, or 5 Hematological Adverse Events (AEs). | Grade 4 | 0 Adverse Events |
| MMF Maintenance | Number of Grade 3, 4, or 5 Hematological Adverse Events (AEs). | Grade 5 | 0 Adverse Events |
| MMF Withdrawal | Number of Grade 3, 4, or 5 Hematological Adverse Events (AEs). | Grade 3 | 0 Adverse Events |
| MMF Withdrawal | Number of Grade 3, 4, or 5 Hematological Adverse Events (AEs). | Grade 4 | 0 Adverse Events |
| MMF Withdrawal | Number of Grade 3, 4, or 5 Hematological Adverse Events (AEs). | Grade 5 | 0 Adverse Events |
Secondary
Number of Infection-Related Adverse Events (AEs)
The number of AEs classified as infections. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The safety population (SP) includes all participants for whom study intervention was initiated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MMF Maintenance | Number of Infection-Related Adverse Events (AEs) | 63 Adverse Events |
| MMF Withdrawal | Number of Infection-Related Adverse Events (AEs) | 49 Adverse Events |
Secondary
Number of Malignancies Reported as Adverse Events (AEs).
The number of malignancies reported as AEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The safety population (SP) includes all participants for whom study intervention was initiated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MMF Maintenance | Number of Malignancies Reported as Adverse Events (AEs). | 2 Adverse Events |
| MMF Withdrawal | Number of Malignancies Reported as Adverse Events (AEs). | 3 Adverse Events |
Secondary
Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 | 20 Participants |
| MMF Withdrawal | Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 | 25 Participants |
95% CI: [-0.116, 0.279]
Secondary
Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF<2000 mg/Day Subgroup
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. MMF: mycophenolate mofetil
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Baseline MMF \<2000 mg/day participants were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF<2000 mg/Day Subgroup | 11 Participants |
| MMF Withdrawal | Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF<2000 mg/Day Subgroup | 13 Participants |
Comparison: The estimated risk difference (i.e. risk(MMF Withdrawal) - risk(MMF Maintenance)) and 95% confidence intervals around the risk difference at Week 60 were reported using the Kaplan-Meier product-limit estimator.95% CI: [-0.286, 0.249]
Secondary
Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. MMF: mycophenolate mofetil
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Baseline MMF \>=2000 mg/day participants were analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup | 9 Participants |
| MMF Withdrawal | Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup | 12 Participants |
95% CI: [-0.09, 0.497]
Secondary
Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Participants in the renal subgroup were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup | 15 Participants |
| MMF Withdrawal | Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup | 19 Participants |
95% CI: [-0.091, 0.36]
Secondary
Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Participants in the non-renal subgroup were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup | 5 Participants |
| MMF Withdrawal | Number of Participants Experiencing a Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup | 6 Participants |
95% CI: [-0.475, 0.333]
Secondary
Number of Participants Experiencing Any British Isles Lupus Assessment Group (BILAG) A Flare by Week 60
The BILAG assesses participants on a variety of disease activity criteria in nine body system categories (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematological). Each category is scored as an A, B, C, or D/E, where A indicates most severe disease activity and D/E indicates inactive/no disease activity. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | Number of Participants Experiencing Any British Isles Lupus Assessment Group (BILAG) A Flare by Week 60 | 1 Participants |
| MMF Withdrawal | Number of Participants Experiencing Any British Isles Lupus Assessment Group (BILAG) A Flare by Week 60 | 4 Participants |
95% CI: [-0.028, 0.149]
Secondary
Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 | 4 Participants |
| MMF Withdrawal | Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 | 8 Participants |
95% CI: [-0.056, 0.211]
Secondary
Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Participants in the renal subgroup were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup | 3 Participants |
| MMF Withdrawal | Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Lupus Nephritis Subgroup | 7 Participants |
95% CI: [-0.041, 0.284]
Secondary
Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Participants in the non-renal subgroup were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup | 1 Participants |
| MMF Withdrawal | Number of Participants Experiencing a Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 Within the Non-Lupus Nephritis Subgroup | 1 Participants |
95% CI: [-0.285, 0.206]
Secondary
Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF <2000 mg/Day Subgroup
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. MMF: mycophenolate mofetil
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Baseline MMF \<2000 mg/day participants were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF <2000 mg/Day Subgroup | 3 Participants |
| MMF Withdrawal | Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF <2000 mg/Day Subgroup | 6 Participants |
95% CI: [-0.118, 0.289]
Secondary
Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup
The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included. MMF: mycophenolate mofetil
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Baseline MMF \>=2000 mg/day participants were analyzed
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup | 1 Participants |
| MMF Withdrawal | Number of Participants Experiencing Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare by Week 60 in the Baseline MMF ≥ 2000 mg/Day Subgroup | 2 Participants |
95% CI: [-0.103, 0.212]
Secondary
Number of Participants in the Lupus Nephritis Subgroup Experiencing a British Isles Lupus Assessment Group (BILAG) A Renal Flare by Week 60
The BILAG assesses participants on a variety of disease activity criteria in nine body system categories (constitutional, mucocutaneous, neuropsychiatric, musculoskeletal, cardiorespiratory, gastrointestinal, ophthalmic, renal, and hematological). Each category is scored as an A, B, C, or D/E, where A indicates most severe disease activity and D/E indicates inactive/no disease activity. An estimate of the risk difference ((i.e. risk(MMF Withdrawal) - risk(MMF Maintenance) and its corresponding 95% confidence interval (CI) were also included.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the group they were randomized. Participants in the renal subgroup were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | Number of Participants in the Lupus Nephritis Subgroup Experiencing a British Isles Lupus Assessment Group (BILAG) A Renal Flare by Week 60 | 0 Participants |
| MMF Withdrawal | Number of Participants in the Lupus Nephritis Subgroup Experiencing a British Isles Lupus Assessment Group (BILAG) A Renal Flare by Week 60 | 2 Participants |
95% CI: [-0.02, 0.134]
Secondary
Number of Serious Adverse Events (SAEs).
The number of SAEs. The severity of AEs was classified using the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 4.0.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The safety population (SP) includes all participants for whom study intervention was initiated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MMF Maintenance | Number of Serious Adverse Events (SAEs). | 12 Serious Adverse Events |
| MMF Withdrawal | Number of Serious Adverse Events (SAEs). | 6 Serious Adverse Events |
Secondary
The Addition of Aggressive Adjunctive Therapy to Mycophenolate Mofetil (MMF) or Change in MMF Therapy to Cytotoxic Drug Due to Flare by Week 60
The addition of aggressive adjunctive therapy could include intravenous (IV) immunoglobulin or rituximab at any point during the participant's study participation. A change in therapy to cytotoxic drug due to flare could include drugs such as cyclophosphamide, etc. A blinded list of study medications was reviewed to identify the addition of aggressive adjunctive therapy or cytotoxic drugs.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups to which they were randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMF Maintenance | The Addition of Aggressive Adjunctive Therapy to Mycophenolate Mofetil (MMF) or Change in MMF Therapy to Cytotoxic Drug Due to Flare by Week 60 | 0 Participants |
| MMF Withdrawal | The Addition of Aggressive Adjunctive Therapy to Mycophenolate Mofetil (MMF) or Change in MMF Therapy to Cytotoxic Drug Due to Flare by Week 60 | 1 Participants |
95% CI: [-0.019, 0.059]
Secondary
Time From Clinically Significant Disease Reactivation to Improvement in British Isles Lupus Assessment Group (BILAG) From Maximum Level During Flare
For each participant who experienced disease reactivation, time from clinically significant disease reactivation to improvement in BILAG from maximum level (at least an A or B) during the flare was calculated in study days as: date of clinically significant disease reactivation minus (-) date of BILAG improvement. If multiple body systems had a BILAG flare at the visit, then the body system with the most severe score was tracked for improvement; if multiple body systems had the same score (at least an A or B), then just one needed to show improvement.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups they were randomized. Participants who met primary endpoint were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MMF Maintenance | Time From Clinically Significant Disease Reactivation to Improvement in British Isles Lupus Assessment Group (BILAG) From Maximum Level During Flare | 114.5 Days | Standard Deviation 123.7 |
| MMF Withdrawal | Time From Clinically Significant Disease Reactivation to Improvement in British Isles Lupus Assessment Group (BILAG) From Maximum Level During Flare | 40.5 Days | Standard Deviation 31.8 |
Secondary
Time From Clinically Significant Disease Reactivation to Recovery to Baseline British Isles Lupus Assessment Group (BILAG) Score or BILAG C
For each participant who experienced disease reactivation, time from clinically significant disease reactivation to recovery to baseline BILAG scores or BILAG C, whichever is worse, was calculated in study days as: date of clinically significant disease reactivation minus (-) date of BILAG recovery.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups they were randomized. Participants who met primary endpoint were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MMF Maintenance | Time From Clinically Significant Disease Reactivation to Recovery to Baseline British Isles Lupus Assessment Group (BILAG) Score or BILAG C | 114.5 Days | Standard Deviation 123.7 |
| MMF Withdrawal | Time From Clinically Significant Disease Reactivation to Recovery to Baseline British Isles Lupus Assessment Group (BILAG) Score or BILAG C | 77.7 Days | Standard Deviation 63.4 |
Secondary
Time From Clinically Significant Disease Reactivation to Return to Pre-Flare Steroid Dose
For each participant who experienced disease reactivation, time from clinically significant disease reactivation to recovery to pre-flare steroid dose was calculated in study days as: date of clinically significant disease reactivation minus (-) date of return to pre-flare steroid dose.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included all randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups they were randomized. Participants who met primary endpoint were analyzed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| MMF Maintenance | Time From Clinically Significant Disease Reactivation to Return to Pre-Flare Steroid Dose | NA Days |
| MMF Withdrawal | Time From Clinically Significant Disease Reactivation to Return to Pre-Flare Steroid Dose | 37 Days |
Secondary
Time to Clinically Significant Disease Reactivation
The time to clinically significant disease reactivation was defined as the time from Baseline/Day 0 to the date of the first Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) assessment that met (or went on to meet) the criteria for clinically significant disease reactivation. Time to clinically significant disease reactivation was defined in study weeks as: date of SELENA-SLEDAI assessment that met reactivation criteria minus (-) baseline date.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups they were randomized. Participants who met disease reactivation were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MMF Maintenance | Time to Clinically Significant Disease Reactivation | 38.0 Weeks | Standard Deviation 18.7 |
| MMF Withdrawal | Time to Clinically Significant Disease Reactivation | 38.5 Weeks | Standard Deviation 19.6 |
Secondary
Time to First Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare
The time to first mild/moderate or severe SELENA-SLEDAI flare was defined as the time from Baseline/Day 0 to the date of the first mild/moderate or severe SELENA-SLEDAI flare. Time to SELENA-SLEDAI flare was defined in study weeks as: date of SELENA-SLEDAI flare minus (-) baseline date. The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups they were randomized. Participants who had SELENA-SLEDAI flares were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MMF Maintenance | Time to First Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare | 20.5 Weeks | Standard Deviation 19.5 |
| MMF Withdrawal | Time to First Mild/Moderate or Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare | 27.5 Weeks | Standard Deviation 16.7 |
Secondary
Time to First Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare
The time to first severe SELENA-SLEDAI flare was defined as the time from Baseline/Day 0 to the date of the first severe SELENA-SLEDAI flare. Time to severe SELENA-SLEDAI flare was defined in study weeks as: date of SELENA-SLEDAI flare minus (-) baseline date. The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and hospitalization due to SLE.
Time frame: Baseline (Treatment Randomization) to Week 60
Population: The modified Intent-to-Treat (mITT) population included randomized participants who begin ALE06-provided MMF and meet study entry criteria. Participants who, for whatever reason, do not complete their assigned therapy will be included in the mITT population in the groups they were randomized. Participants who had SELENA-SLEDAI flares were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MMF Maintenance | Time to First Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare | 43.5 Weeks | Standard Deviation 9.9 |
| MMF Withdrawal | Time to First Severe Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus-Disease Activity Index (SELENA-SLEDAI) Flare | 41.5 Weeks | Standard Deviation 17.5 |